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PiXL for Correction of Hyperopia

Primary Purpose

Hyperopia

Status
Unknown status
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
PiXL
Sponsored by
Gemini Eye Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperopia focused on measuring Hypeorpia, Crosslinking, PiXL

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • low hyperopia of spherical equivalent from +0.5 up to +1.75 D sp. eq.
  • astigmatism up to 0.75 Dcyl
  • corneal thickness above 400 µm
  • endothelial cell density above 1500 cell/mm2

Exclusion Criteria:

  • any prior corneal surgery or any eye surgery within the last 3 months,
  • any corneal pathology e.g. corneal scar or dystrophy
  • unstable refraction
  • patient not able to understand and sign informed consent
  • patients with connective tissue disorder or uncontrolled diabetes
  • pregnant or lactating women
  • aphakic eyes or pseudophakic eyes without UV blocking IOL

Sites / Locations

  • Gemini Eye Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Photorefractive intrastromal corneal crosslinking (PiXL)

Arm Description

Patients undergo PiXL where the UVA light is delivered in customized patterns and corneal changes are achieved. For hyperopia, a ring shape irradiation is used to steepen the central cornea. An oxygen mask is used to enhance the crosslinking efficacy. A dedicated riboflavin formulation penetrates the corneal stroma. Pulsed UVA light with oxygen triggers the covalent bonds of collagen strands in riboflavin soaked cornea.

Outcomes

Primary Outcome Measures

Change in Uncorrected Distance Visual Acuity
Best distance visual acuity tested without any correction
Change in Subjective Refraction
Spherical and cylindrical correction

Secondary Outcome Measures

Change in keratometry
Change in keratomery parameter K2-K1provided by Pentacam
Change in Higher Order Aberrations
Higher Order Aberrations assessed using Pentacam
Change in pachymetry
Change in mean cornea thickness in 8.0 mm ring provided by Pentacam
Subjective questionnaire score
Questionnaire assessing participants discomfort at 6 months in respect to their photophobia, pain and dry eye.
Change in Corrected Distance Visual Acuity
Best distance visual acuity tested with the best correction
Change in Spherical aberration
Spherical aberration assessed using Pentacam

Full Information

First Posted
January 10, 2019
Last Updated
February 2, 2021
Sponsor
Gemini Eye Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03805425
Brief Title
PiXL for Correction of Hyperopia
Official Title
Photorefractive Intrastromal Corneal Crosslinking (PiXL) for Correction of Hyperopia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (Actual)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
March 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gemini Eye Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This clinical study aims to investigate the efficacy and safety of PiXL in the refractive correction of low hyperopia.
Detailed Description
This clinical study aims to investigate the efficacy and safety of PiXL in the refractive correction of low hyperopia.Slightly modified settings from previously published study is applied to eyes with low hyperopia with an expected refractive change of 0.75 D. Aim is to evaluate the refractive outcome of this procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperopia
Keywords
Hypeorpia, Crosslinking, PiXL

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Photorefractive intrastromal corneal crosslinking (PiXL)
Arm Type
Experimental
Arm Description
Patients undergo PiXL where the UVA light is delivered in customized patterns and corneal changes are achieved. For hyperopia, a ring shape irradiation is used to steepen the central cornea. An oxygen mask is used to enhance the crosslinking efficacy. A dedicated riboflavin formulation penetrates the corneal stroma. Pulsed UVA light with oxygen triggers the covalent bonds of collagen strands in riboflavin soaked cornea.
Intervention Type
Radiation
Intervention Name(s)
PiXL
Intervention Description
The system is set to deliver 30 mW/cm2 UVA irradiance in pulsed intervals of 1 second on and 1 second off to 5 to 9 mm diameter corneal annulus. Total energy delivered is 15J.
Primary Outcome Measure Information:
Title
Change in Uncorrected Distance Visual Acuity
Description
Best distance visual acuity tested without any correction
Time Frame
Month 12
Title
Change in Subjective Refraction
Description
Spherical and cylindrical correction
Time Frame
Month 12
Secondary Outcome Measure Information:
Title
Change in keratometry
Description
Change in keratomery parameter K2-K1provided by Pentacam
Time Frame
Month 12
Title
Change in Higher Order Aberrations
Description
Higher Order Aberrations assessed using Pentacam
Time Frame
Month 12
Title
Change in pachymetry
Description
Change in mean cornea thickness in 8.0 mm ring provided by Pentacam
Time Frame
Month 12
Title
Subjective questionnaire score
Description
Questionnaire assessing participants discomfort at 6 months in respect to their photophobia, pain and dry eye.
Time Frame
Month 12
Title
Change in Corrected Distance Visual Acuity
Description
Best distance visual acuity tested with the best correction
Time Frame
Month 12
Title
Change in Spherical aberration
Description
Spherical aberration assessed using Pentacam
Time Frame
Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: low hyperopia of spherical equivalent from +0.5 up to +1.75 D sp. eq. astigmatism up to 0.75 Dcyl corneal thickness above 400 µm endothelial cell density above 1500 cell/mm2 Exclusion Criteria: any prior corneal surgery or any eye surgery within the last 3 months, any corneal pathology e.g. corneal scar or dystrophy unstable refraction patient not able to understand and sign informed consent patients with connective tissue disorder or uncontrolled diabetes pregnant or lactating women aphakic eyes or pseudophakic eyes without UV blocking IOL
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pavel Stodulka, MD, PhD
Organizational Affiliation
Gemini Eye Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gemini Eye Clinic
City
Zlín
ZIP/Postal Code
760 01
Country
Czechia

12. IPD Sharing Statement

Citations:
PubMed Identifier
25506204
Citation
Kanellopoulos AJ, Asimellis G. Hyperopic correction: clinical validation with epithelium-on and epithelium-off protocols, using variable fluence and topographically customized collagen corneal crosslinking. Clin Ophthalmol. 2014 Dec 2;8:2425-33. doi: 10.2147/OPTH.S68222. eCollection 2014.
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PiXL for Correction of Hyperopia

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